What is FDA product code OGP?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance

NAR Kit · Cricothyrotomy Kit → Anesthesiology

Name: NAR Kit
Brand: NAR Kit

1manufacturer

5catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code OGP
Manufacturer	City	Province	Registered as	Device types
Well Lead Medical Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	46

Record

Regulatory record for NAR Kit
Listed by	North American Rescue, LLC., United States
FDA product code	OGP
Device type	Cricothyrotomy Kit
Device class	Class 2
Regulation	21 CFR 868.5800
Establishment	Specification developer, Repacker / relabeller, Manufacturer
Record published	2018-10-17
Record revised	2022-03-15 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for NAR Kit
Catalogue number	Size	Status
85-2232		In distribution
85-1162		In distribution
85-2324		In distribution
10-0052		In distribution
85-2290		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Motion Medical Distributing	Haslam Medical, Inc.	25
Curaplex	Bound Tree Medical, LLC	23
NAR	North American Rescue, LLC.	13
Tactical CricKIT	North American Rescue, LLC.	9
Cardinal Health	Cardinal Health 200, LLC	8
Forward	Synchronis Medical LLC	2
Endotracheal Kit	NAR Medical Depot, LLC	2
H&H Emergency Cricothyrotomy Kit	H & H Co.	1
TMM-CR-SO (Tactical Medical Module – Cricothyroidotomy Special Operations)	Altitude Technologies Inc.	1
Emergency Cric Kit	Safeguard US Operating, LLC	1
ReadyCric Kit	H & H Co.	1
TMM-BCR-Tactical Medical Module Bougie Assisted Cricothyrotomy	Altitude Technologies Inc.	1

Showing 12 of 22. All products under Cricothyrotomy Kit

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

NAR Kit

Who Else Makes It

Record

Specifications

Catalogue Numbers

Same Product Code

Where China Actually Supplies